Letter opposes possible EPA shift

Letter opposes possible EPA shift

The letter, drafted by Law School Professor Wendy Jacobs (pictured), asks the EPA to withdraw a proposal that would require that the raw data of any study used to inform policy be publicly available, saying the rule would exclude key studies and harm human health.

Asia Kepka/Harvard Law School

Harvard officials, hospital leaders call on agency to withdraw proposed ‘transparency’ rule, which they say would bar use of best science data

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Nearly 100 leaders and faculty members at Harvard and its affiliated hospitals have signed a letter calling on the Environmental Protection Agency (EPA) to withdraw its proposed rule on scientific “transparency,” saying that the change would drastically limit the scientific and medical knowledge that underlies a host of EPA regulations that protect human health.

“It does not get at what they’re trying to do,” said Francine Laden, professor of environmental epidemiology at the Harvard Chan School and one of the signatories. “Having data available for anybody to look at does not guarantee you have validity.”

The letter was drafted by Wendy Jacobs, Emmett Clinical Professor of Environmental Law and director of Harvard Law School’s Emmett Environmental Law and Policy Clinic, together with clinic staff and with input from faculty members about the rule’s potential scientific and health ramifications. It was submitted to the EPA on Tuesday during the public comment period on the proposed rule, which is called “Strengthening Transparency in Regulatory Science.”

Data transparency does not guarantee valid, high-quality science. In the scientific community, study quality is judged not by transparency but by scientific methodology and the rigor with which studies are conducted.

The letter, which concludes by urging the EPA to withdraw the draft rule, is one of two that Jacobs said the clinic will submit. The second will focus in more detail on what she described as the rule’s numerous legal deficiencies.

The rule would require that the raw data supporting scientific conclusions on which EPA regulations are based be publicly available. Supporters of the move — including former EPA Administrator Scott Pruitt, who submitted the proposal in April — argue that the rule would allow the underlying science to be independently validated. In announcing the proposal, Pruitt hailed the end of “the era of secret science at the EPA” and said the reproducibility that it would enable is “vital for the integrity of the rulemaking process.”

The proposal quickly drew criticism from analysts and scientists concerned about its impact on EPA regulations. In May, members of the EPA’s own Science Advisory Board criticized the proposal, saying it was drafted without input from scientists. A month later, then-Harvard President Drew Faust wrote to Pruitt that his criticism of “secret science” misrepresented a process that has an obligation both to use private health information for the greater good and to protect subjects’ privacy.

Tuesday’s letter points out that health studies on human subjects are typically conducted on condition of confidentiality. In fact, protecting subjects’ identities is not just common practice, but in many cases is required by laws such as the federal Health Insurance Portability and Accountability Act (HIPAA) and by contracts between researchers and research subjects.

“When an individual gives private information with the promise it’ll be protected, that promise is important,” said Laden, a past member of the Science Advisory Board and the first author of follow-up studies to the 1993 Harvard Six Cities Study, whose results led to EPA restrictions on fine particles a few years later.

Because of those privacy guarantees, the letter said, the transparency requirement would mean that many key studies documenting harm from air, water, chemical, and other environmental pollution would not inform EPA regulations. The general effect would be to keep many findings of harm to human health from being considered in the rulemaking process.

“Most human health studies contain protected health information. This rule threatens the bedrock of what the medical community stands for [and] the health of all of us.”

Renee Salas, instructor in emergency medicine at HMS and MGH and researcher with the Harvard Global Health Institute

“Most human health studies contain protected health information,” said Renee Salas, an instructor in emergency medicine at HMS and MGH, a signatory of the letter and a researcher at the Harvard Global Health Institute into the effects of climate change on human health. “This rule threatens the bedrock of what the medical community stands for. … From my physician/researcher perspective, this proposed rule threatens the health of all of us.”

The letter also said that data transparency does not guarantee valid, high-quality science. In the scientific community, study quality is judged not by transparency but by scientific methodology and the rigor with which studies are conducted. Procedures are described in detail in scientific journals, which have a process of prepublication peer review. Publication itself opens a study’s methodology, results, and analysis to additional review and criticism.

Jacobs said that the Harvard letters will become an important part of the administrative record on the proposal. Federal law guarantees the right to participate in the process of how regulations are crafted during the public comment period — which in this case closes Aug. 16 — and even to challenge a final rule in court if it is considered arbitrary, capricious, or violates a statute. The right to sue, however, is limited if plaintiffs have not participated in the public-comment process. Jacobs said it is incumbent on the public to advise the agency of specific concerns about a proposed rule so the agency cannot say in court that it was blindsided.

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“This is why these letters are so important,” Jacobs said. “The public has the right to participate, but if we, the public, didn’t bring our concerns to the agency’s attention, then the agency can’t be bound to act on those concerns.”

Jacobs said the proposed rule would undermine the EPA’s statutory obligations to protect public health because its overall effect would be to deprive the agency of critically important data and analyses about the need for regulations, and their demonstrable benefits. As a result, the costs of public health regulations would erroneously appear to be heftier than the benefits. She is also concerned that if the rule’s data-transparency approach were extended to other parts of the government, that could harm public health in other ways. For example, requiring disclosure of raw data would impede the Food and Drug Administration’s ability to approve new drugs.

“EPA is mandated by the various environmental and public health protection statues to use ‘best available,’ ‘reasonably available,’ ‘latest’ scientific data — the standard changes depending on the statute,” Jacobs said. “By excluding that data … EPA would be depriving itself of the best available science, reasonably available science, the latest science.”